Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women With Chronic Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00001890

Recruitment Status : Completed

First Posted : December 10, 2002

Last Update Posted : March 4, 2008

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

Study Description

Brief Summary:

Hardening of the arteries (atherosclerosis) and heart disease are much more common in men than in women. However, as women grow older, especially after menopause the incidence of atherosclerosis and heart disease increases. These findings suggest that estrogen may be protective and help in preventing heart disease.

Studies of large groups of post-menopausal women suggest that hormone replacement therapy (therapy that includes estrogen) reduces the risk of heart disease. Estrogen causes favorable changes in particles that carry cholesterol in the blood stream and improves function of blood vessels. Estrogen may also stimulate the immune system's ability to fight off infections that may lead to or contribute to atherosclerosis.

Researchers believe two specific infectious agents (Chlamydia pneumoniae and human cytomegalovirus) may cause damage to the lining of blood vessels resulting in inflammation and the development of atherosclerosis.

The purpose of this study is to determine if estrogen treatment can change how the immune system responds to chronic infections, by Chlamydia pneumoniae and human cytomegalovirus, in postmenopausal women.

Condition or disease	Intervention/treatment	Phase
Atherosclerosis Chlamydia Infections Cytomegalovirus Infections Pneumonia, Bacterial Postmenopause	Drug: Estrogen therapy	Phase 2

Detailed Description:

The incidence of atherosclerotic cardiovascular disease in women does not approach rates seen in men until approximately a decade following menopause, suggesting that estrogen is vasculoprotective. Infectious pathogens such a Chlamydia pneumoniae (C. pneumoniae) and human cytomegalovirus (hCMV) have been implicated in the pathogenesis of atherosclerosis. Experimental studies in cultured lymphocytes and animals suggest that estrogen stimulates cell-mediated immune responsiveness, observations that are potentially relevant to the eradication of intracellular pathogens including C. pneumoniae and hCMV. The purpose of this study is to determine whether estrogen therapy augments cell-mediated immune responsiveness in estrogen-deficient postmenopausal women who have serologic evidence of chronic infection with C. pneumoniae and/or hCMV. A comparison will be made between seropositive and seronegative women. We propose that estrogen therapy will stimulate a more efficient cell-mediated response to these chronically persistent infectious intracellular pathogens, resulting in eradication of these organisms that are of potential importance in atherogenesis.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Enrollment :	80 participants
Primary Purpose:	Treatment
Official Title:	Immunomodulatory Effects of Hormone Therapy in Postmenopausal Women With Chronic Chlamydia Pneumoniae or Cytomegalovirus Infection
Study Start Date :	May 1999
Study Completion Date :	March 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chlamydia Infections Hormones Immune System and Disorders Pneumonia

Drug Information available for: Estrogens

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease Cytomegalic Inclusion Disease

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Must be a postmenopausal woman 65 years of age or younger.

Time since last date of menses should be at least 12 months, with plasma estradiol less than 50 pg/ml and FSH greater than 50 pg/ml.

Women must be without clinical evidence of CAD as determined by history, cardiovascular physical examination, and EKG.

Must not have used hormone replacement therapy within past 6 months.

Must not have used dietary supplements and any medication (over-the-counter or prescribed) within 1 month. Acetaminophen use is allowed.

Must not have a history of alcoholism or binge-drinking.

Must not have diabetes mellitus or known abnormal glucose intolerance test.

Must not have a history of stroke, angina or myocardial infarction.

Must not have a history of deep venous thrombosis/pulmonary embolism.

Must not have a history of cancer (except for treated squamous cell and basal cell carcinomas).

Must not have evidence of liver disease (liver function enzymes greater than twice the upper limit of normal).

Must not have impaired renal function (creatinine greater than 1.6 mg/dl).

Must not have a diagnosis of an autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, thyroiditis, Raynaud's Disease).

Must not have a history of intermittent vaginal bleeding.

Must not have serum triglycerides greater than 400 mg/dL.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001890

Locations

Layout table for location information

United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

More Information

Publications:

Ross R. The pathogenesis of atherosclerosis: a perspective for the 1990s. Nature. 1993 Apr 29;362(6423):801-9. doi: 10.1038/362801a0.

Danesh J, Collins R, Peto R. Chronic infections and coronary heart disease: is there a link? Lancet. 1997 Aug 9;350(9075):430-6. doi: 10.1016/S0140-6736(97)03079-1.

Gaydos CA, Summersgill JT, Sahney NN, Ramirez JA, Quinn TC. Replication of Chlamydia pneumoniae in vitro in human macrophages, endothelial cells, and aortic artery smooth muscle cells. Infect Immun. 1996 May;64(5):1614-20. doi: 10.1128/iai.64.5.1614-1620.1996.

Layout table for additonal information

ClinicalTrials.gov Identifier:	NCT00001890
Other Study ID Numbers:	990100 99-H-0100
First Posted:	December 10, 2002 Key Record Dates
Last Update Posted:	March 4, 2008
Last Verified:	May 2000

Keywords provided by National Institutes of Health Clinical Center (CC):


Cellular Immunity Cytokines Estrogen Humoral Immunity	Progesterone Chlamydia Pneumoniae Human Cytomegalovirus Postmenopause

Additional relevant MeSH terms:

Layout table for MeSH terms

Infections Communicable Diseases Pneumonia Cytomegalovirus Infections Chlamydia Infections Pneumonia, Bacterial Atherosclerosis Disease Attributes Pathologic Processes Respiratory Tract Infections Lung Diseases Respiratory Tract Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases	Cardiovascular Diseases Herpesviridae Infections DNA Virus Infections Virus Diseases Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Genital Diseases Urogenital Diseases Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

To Top